BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20622630 · Received November 6, 2024

    Report

    Report Number
    3002682307-2024-00236
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 18, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 240203. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES OF REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EVALUATED; HOWEVER, NO ISSUES WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE AND AN EXACT CAUSE COULD NOT BE DETERMINED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. WE WOULD LIKE TO INFORM YOU THAT INTRAOCULAR USE IS NOT VALIDATED BY BD FOR THIS PRODUCT. PLEASE CONTACT YOUR LOCAL BD SALES AND MARKETING ORGANIZATION FOR ASSISTANCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E. FACILITY NAME EXCEEDS CHARACTER LIMIT: (B)(6) PHARMASTE. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    (B)(6) 2024 2. HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? ="UNINJURED PATIENT" 3. DID MALFUNCTION CAUSED NEEDLE STICK INJURY TO HEALTHCARE WORKER OR PATIENT? ="UNINJURED PERSONNEL" 4. HAVE ANY OTHER ACTIONS BEEN TAKEN? ="ISOLATED LOT=TO RECOVER TO HAVE=SEVERAL BOXES+BULK".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES EPOXY ON NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE LOT NON-CONFORMING CERTISSAGE: GLUE DEPOSIT ON NEEDLE GUARD. RISK OF PARTICLES BEING DEPOSITED IN PATIENTS' EYES AND RISK OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460298 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240203 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown